Every doctor in the country should be required to attend mandatory advanced training in pain management and the prescribing of opioid painkillers, says a joint FDA advisory panel.

The panel of experts was meeting to ascertain the effectiveness of the FDA’s 2013 risk evaluation and mitigation strategy (REMS) for prescribing extended release /long acting (ER/LA) opioids.

The panelists concluded that there was no way to accurately tell if the FDA’s ER/LA REMS program has had anything to do with recent declines in prescription opioid abuse, overdose and death statistics.

Instead, the panelists recommended that the REMS program be expanded to include immediate release (IR) opioids as well as ER/LA opioids. Even more important, it should focus on overall treatment of pain, not just on the uses of opioids.

“I almost voted to eliminate the REMS, because there’s been very little evidence that it altered behavior much at all,” said panelist Mary Ellen McCann, MD, in MedPage Today. “Instead I voted to modify it, because it’s a manual on how to prescribe opioids, when it should be a blueprint on how to treat pain.”

There is little or no evidence supporting the long-term use of opioids for chronic non-cancer pain. As well as being generally ineffective, long-term opioid use is seen as contributory to dependence and abuse. Various panelists have gone on record in the past as opposed to the use of opioids as a first-line treatment for chronic non-cancer pain.

Tobias Gerhard, PhD, of Rutgers University’s Ernest Mario School of Pharmacy, said that the expanded REMS program “should focus on pain management broadly, and the role of opiates within this context, rather than being about the use of opiates. It should focus on evidence-based use of opioids … and emphasize their risk.”

REMS response was low and slow

Only a third of the 3 million physicians for whom the continuing education training was considered relevant even read the “Dear Reader” letters from the FDA detailing the new voluntary REMS courses.

In this first three years of the REMS program, there have been 839 continuing education courses and 438,461 sporadic attendees. However, just a tad over 15 percent – 157,493 – of the original 3 million invited physicians completed all the courses. And only 66,219 of those completions – 41 percent – are from the proposed figure of 160,000 ER/LA prescribers targeted to be through the training by now.

On the positive side, surveys indicate that 83 percent of prescribers understood the material well, as did 86 percent of their patients, said MedPage Today.

Is REMS working or not?

Although the panel couldn’t nail down any real specifics, there are some indications that the REMS program might be having a palliative effect on prescription painkiller abuses. Pharma industry observational studies showed declining rates of abuse, overdose, and death.

Richard Dart, MD, director of the Rocky Mountain Poison and Drug Center in Denver (run with funding from the pharmaceutical industry) also showed data supporting declining rates, but said there’s no solid data supporting REMS as the reason for the decline.

Charles Argoff, MD, from Albany Medical College in New York, presented a study showing that physicians who had REMS training had a 10 percent drop in ER/LA prescribing, compared with a 4 percent increase among untrained physicians.

But Jana McAninch, MD, of the epidemiology division of the Center for Drug Evaluation and Research at the FDA, pointed out that decreases in abuse, overdoses and death actually started before the REMS program began in 2013. Various other initiatives, such as the White House funding and grant programs, were already running.

McAninch added that declines were already also occurring with immediate-release opioids and benzodiazepines, neither of which are covered by the current ER/LA REMS. “Is REMS making any progress? That’s a difficult question to answer,” she said. “Evaluating the effectiveness of an intervention using only observational data is inherently challenging.”

Mandatory training and immediate release opioids

The FDA expert panelists agreed that REMS training should be mandatory, perhaps licensed through the Drug Enforcement Administration (DEA) or some other agency or official group.

Also, IR opioids represent an enormous percentage of opioid prescriptions and play a big role in abuse, overdose and deaths. Adding IR painkillers such as Vicodin and Percocet to the REMS was widely agreed.

Finally, the panelists recommended that the FDA end pharmaceutical industry funding of the REMS continuing education courses. The current program is funded by more than 20 opioid drug makers.

“The role of industry needs to be separated from education,” said Linda Tyler, PharmD, of the University of Utah in Salt Lake City.

Happy to see progress being made

As we said last year when we reported on the new CDC opioid prescribing guidelines, here at Novus we’re happy to see more attention being paid to the problems associated with opioid painkillers. We hope the FDA moves quickly to implement the recommendations of its expert REMS panelists.

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